ATN 166: CHOOSE

Study Summary:

Pre-exposure prophylaxis (HIV PrEP) is a pill or a shot that can prevent HIV infection. Doxycycline, an antibiotic, can be taken after sex by men and transgender women to prevent sexually transmitted infections (STIs) – this approach is called DoxyPEP. The CHOOSE Study (Combatting HIV Or Other STIs Early) is a study to help young gay, bisexual, and other sexual minority men (YGBSMM) to decide if HIV PrEP and DoxyPEP are good options for them, and to help them to take these highly effective prevention tools.

What is the study trying to discover?

The goal of CHOOSE is to determine whether a package of 3 mobile health tools can help YGBSMM to choose which type of HIV PrEP may work best for them, and to support them in taking these HIV PrEP medications. The 3 tools are:

1. MyPrEP website: A decision support tool to help participants decide which type of HIV PrEP they want to take;
2. PrEPsmart: An app that helps oral HIV PrEP users (daily and 2-1-1) to determine when their next PrEP dose is due, and CAB-LA users determine when their next injection visit is due; and
3. PrEPmate: An SMS texting platform to allow bidirectional communication between the participant and the SC, including regular check-ins to triage those participants needing additional assistance in taking HIV PrEP.

This study will also offer DoxyPEP to all YGBSMM in the study and determine who is interested in taking it and whether they take it as recommended.

Why is this study important?

Rates of new HIV and STIs are high among YGBSMM. HIV PrEP is highly effective in preventing HIV infection, and DoxyPEP is highly effective in preventing STIs. There are now 4 choices of HIV PrEP for YGBSMM to choose from (including pills taken every day or before/after sex, and an injectable medication taken every 2 months), and to make a choice that works best for them, YGBSMM may need more information about these different forms of HIV PrEP. Furthermore, people may need support in knowing when to take their next pill or come in for their next injection, and may want to be able to talk with a provider about any difficulties they are having using either HIV PrEP or DoxyPEP. This combination of mobile health tools may help people be successful in taking HIV PrEP and DoxyPEP.

Who is this study for?   

This study will initially enroll 24-32 English- or Spanish-speaking YGBSMM to help us finalize the 3 HIV PrEP support tools. Then, 20 YGBSMM will test the tools for 3 months. Finally, 200 YGBSMM will participate in an 18-month study to see whether these tools will help people take HIV PrEP, and to understand who uses Doxy-PEP, whether they are able to take it as recommended, and how well it works.

What happens during the study?

In the main part of the study, 100 YGBSMM will be randomly chosen to get the 3 mobile health tools immediately, while the other 100 participants will get the 3 mobile health tools after 9 months in the study. All participants will have free access to the different HIV PrEP options and DoxyPEP, and will receive counseling about these different prevention tools. Participants will be seen every 2-3 months for visits to receive HIV PrEP and Doxy-PEP, answer study questions, and undergo HIV and STI testing.